2D Bioprocessing Associate II

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.

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JOB SUMMARY:

The 2D Bioprocessing Associate II participates in the hands-on production of Humacyte’s regenerative vessels.

ESSENTIAL FUNCTIONS:

Performs basic/moderate scope processes and serves as a hands-on resource in manufacturing Humacyte’s regenerative vessels by:

• Performing daily activities required of vessel production
• Partnering with other Bioprocessing Team Members during launches
• Recognizing and solving typical problems that occur in own work area without supervisory approval
• Supporting projects of moderate scope (e.g. operational excellence, safety)
• Supporting the collection and tracking of area metrics and process control data
• Performing cleaning and preparation of production equipment, and cleaning/disinfecting of production rooms
• Supporting the assembly, set-up, and disassembly of production equipment
• Ensuring process steps are executed according to defined SOPs and BPRs
• Ensuring proper documentation of activities in accordance with cGMPs
• Adhering to the proper handling of chemically hazardous goods
• Interfacing with process automation and electronic business systems
• Supporting the revisions of SOPs and BPRs
• Supporting qualifications and validation activities, as assigned
• In collaboration with Bioprocessing leadership, recognizing, troubleshooting, and initiating deviations for process issues of moderate scope
• Supporting team effort in the effective and timely completion of root cause investigations and CAPA implementation
• Training other team members on minor tasks and equipment
• Other duties, as assigned

EXPERIENCE & QUALIFICATIONS:

• High School Diploma or GED, required. Associate or Bachelor’s degree, preferred.
• 2+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required
• Basic knowledge of cGMP requirements, required
• Experience executing SOPs and documenting work, required
• Basic mechanical aptitude or knowledge of electrical / mechanical equipment, preferred
• Previous cell culture experience, highly preferred
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working holidays, weekends and overtime

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with…